Trials@uspto.gov
`571-272-7822
`
`Paper 85
`Entered: February 23, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01343
`Patent RE46,116 E
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`Opinion for the Board filed by Administrative Patent Judge TARTAL.
`Opinion Concurring by Administrative Patent Judge PAULRAJ.
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`ORDER
`Denying Petitioner’s Motion to Exclude
`37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`571-272-7822
`
`Paper 85
`Entered: February 23, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01343
`Patent RE46,116 E
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`Opinion for the Board filed by Administrative Patent Judge TARTAL.
`Opinion Concurring by Administrative Patent Judge PAULRAJ.
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`ORDER
`Denying Petitioner’s Motion to Exclude
`37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`We have jurisdiction to conduct this inter partes review
`under 35 U.S.C. § 6. This Final Written Decision is issued pursuant
`to 35 U.S.C. § 318(a) (2018) and 37 C.F.R. § 42.73 (2019). Medtronic, Inc.
`and Medtronic Vascular, Inc. (“Petitioner”)1 contends that claims 25–40, 42,
`44–48, 52, and 53 (“the Challenged Claims”) of U.S. Patent No. RE46,116 E
`(Ex. 1001, “the ’116 patent”) are unpatentable. For the reasons discussed
`below, we determine that Petitioner has shown by a preponderance of the
`evidence that each of claims 52 and 53 of the ’116 patent is unpatentable,
`but has not shown by a preponderance of the evidence that any of claims 25–
`40, 42, and 44–48 of the ’116 patent is unpatentable.
`INTRODUCTION
`I.
`A. Summary of Procedural History
`Petitioner filed a Petition pursuant to 35 U.S.C. §§ 311–319
`requesting an inter partes review of the Challenged Claims. Paper 1
`(“Pet.”). We instituted an inter partes review of the Challenged Claims on
`all grounds of unpatentability asserted in the Petition. Paper 9 (“Inst. Dec.”).
`Teleflex Life Sciences Limited (“Patent Owner”)2 filed a Patent Owner
`Response.3 Paper 21 (“PO Resp.”) (under seal), 22 (redacted, publicly
`
`
`1 Petitioner identifies as real parties-in-interest Medtronic, Inc. and
`Medtronic Vascular, Inc., and states, “Medtronic plc is the ultimate parent of
`Medtronic Inc.” Pet. 5.
`2 Patent Owner identifies as real parties-in-interest Teleflex Life Sciences
`Limited; Teleflex Medical Devices S.À.R.L.; Vascular Solutions LLC;
`Arrow International, Inc., and Teleflex LLC. Paper 4, 2. Patent Owner also
`states “Teleflex Incorporated is the ultimate parent of the entities listed
`above.” Id.
`3 Prior to institution, Patent Owner filed a Preliminary Response directed
`primarily to whether discretionary denial of the Petition was warranted, not
`to the merits of Petitioner’s unpatentability contentions. See Paper 7.
`
`2
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`IPR2020-01343
`Patent RE46,116 E
`accessible). Petitioner filed a Reply to the Patent Owner Response.
`Paper 46 (“Pet. Reply”) (under seal), 47 (redacted, publicly accessible).
`Patent Owner filed a Sur-reply in support of the Patent Owner Response.
`Paper 59 (“PO Sur-reply”).
`Following oral argument, we entered a transcript of the hearing in
`the record. Paper 84 (“Tr.”). Petitioner bears the burden of proving
`unpatentability of each claim it has challenged by a preponderance of the
`evidence, and the burden of persuasion never shifts to Patent Owner.
`See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d); Dynamic Drinkware, LLC v.
`Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`B. Related Proceedings
`Petitioner challenges claims 25–55 of the ’116 patent under separate
`grounds in IPR2020-01344. Pet. 6; Paper 4, 3. The parties identify the ’116
`patent as a subject of: (1) Vascular Solutions LLC, et al. v. Medtronic, Inc.,
`et al., No. 19-cv-01760 (D. Minn.), and (2) QXMedical, LLC v. Vascular
`Solutions, LLC, No. 17-cv-01969 (D. Minn.). Pet. 5–6; Paper 4, 2. Patent
`Owner states that both of these district court proceedings are currently
`stayed. Paper 4, 2. The parties further state that the ’116 patent is a reissue
`of the ʼ850 patent and that the ’850 patent was a subject of: (1) Vascular
`Solutions, Inc. v. Boston Scientific Corp., No. 13-cv-01172 (D. Minn.),
`and (2) Boston Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00762,
`IPR2014-00763 (PTAB, terminated). Pet. 6; Paper 4, 2–3.
`Additionally, Petitioner filed petitions challenging patents related to
`the ’116 patent in the following proceedings: IPR2020-00126 and IPR2020-
`00127 (Patent 8,048,032 B2); IPR2020-00128, IPR2020-00129, IPR2020-
`00130, and IPR2020-00131 (Patent RE45,380 E); IPR2020-00132,
`IPR2020-00133, and IPR2020-00134 (Patent RE45,760 E); IPR2020-00135
`
`3
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`IPR2020-01343
`Patent RE46,116 E
`and IPR2020-00136 (Patent RE45,776 E); IPR2020-00137 and IPR2020-
`00138 (Patent RE47,379 E); and IPR2020-01341 and IPR2020-01342
`(Patent 8,142,413 B2). Institution of inter partes review was denied in
`IPR2020-00131 and IPR2020-00133.
`C. The ’116 Patent
`The ’116 patent, titled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued August 23, 2016, from Application
`No. 14/195,435, filed March 3, 2014. Ex. 1001, codes (21), (22), (45), (54).
`The ’116 patent is a reissue of U.S. Patent No. 8,292,850 (“the ’850 patent”)
`from Application No. 13/359,059 filed on January 26, 2012, which
`the ’116 patent states is a continuation of an application filed on
`November 1, 2013 (issued as U.S. Patent No. RE45,380), which is an
`application for the reissue of U.S. Patent No. 8,292,850, which is a division
`of an application filed on June 28, 2010 (issued as U.S. Patent
`No. 8,142,413), which is a division of an application filed on May 3, 2006
`(Application No. 11/416,629 (“the ’629 application”), issued as U.S. Patent
`No. 8,048,032). Id. codes (60), (64). The ’116 patent is directed to
`“methods and apparatus for increasing backup support for catheters inserted
`into the coronary arteries from the aorta.” Id. at 1:38–40.
`The ’116 patent explains, as background, that in “[i]nterventional
`cardiology procedures,” guidewires or other instruments, such as balloon
`catheters and stents, are often inserted through guide catheters into coronary
`arteries that branch off from the aorta. Id. at 1:44–50. In coronary artery
`disease, “the coronary arteries may be narrowed or occluded by
`atherosclerotic plaques or other lesions” in a phenomenon known as
`stenosis. Id. at 1:50–54. In treating the stenosis, “a guide catheter is
`inserted through the aorta and into the ostium of the coronary artery,”
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`Patent RE46,116 E
`sometimes with the aid of a guidewire, and is passed beyond the occlusion
`or stenosis. Id. at 1:59–65. However, according to the ’116 patent,
`“[c]rossing tough lesions can create enough backward force to dislodge the
`guide catheter from the ostium of the artery being treated,” which “can make
`it difficult or impossible for the interventional cardiologist to treat certain
`forms of coronary artery disease.” Id. at 1:66–2:3.
`The ’116 patent discusses four categories of previous “attempts to
`provide support to the guiding catheter to prevent backward dislodgement
`from the coronary ostium (referred to as ‘backup support’).” Id. at 2:4–7.
`One category of guiding catheters “are configured to draw backup support
`from engaging the wall of the aortic arch opposing the ostium of the
`coronary artery that is being accessed.” Id. at 2:8–11. A second category
`are “guiding catheters that include a retractable appendage. Id. at 2:25–26.
`A third category are “guide catheters that have a portion that seeks to expand
`laterally to grip the interior wall of the ostium.” Id. at 2:36–41. A fourth
`category, or “technique,” of the prior attempts “includes the placement of a
`smaller guide catheter within a larger guide catheter in order to provide
`added support for the crossing of lesions or for the distal delivery of balloons
`and stents.” Id. at 2:50–53. The ’116 patent states this fourth technique was
`described in Takahashi,4 which uses a guide catheter inserted “more deeply
`into the ostium of the coronary artery than typically has been done before.”
`Id. at 2:53–62. The ’116 patent states that such “deep seating” by this
`technique “creates the risk that the relatively stiff, fixed curve, guide catheter
`will damage the coronary artery.” Id. at 2:63–65.
`
`4 Saeko Takahashi, et al., New Method to Increase a Backup Support
`of a 6 French Guiding Coronary Catheter, 63 CATHETERIZATION AND
`CARDIOVASCULAR INTERVENTIONS 452–456 (2004) (Ex. 1010, “Takahashi”).
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`Patent RE46,116 E
`The ’116 patent purports to resolve issues identified with the prior
`procedures by using “a coaxial guide catheter that is deliverable through
`standard guide catheters by utilizing a guidewire rail segment to permit
`delivery without blocking use of the guide catheter.” Id. at 3:20–23.
`According to the ’116 patent, the coaxial guide catheter “preferably includes
`a tapered inner catheter that runs over a standard 0.014 inch coronary
`guidewire to allow atraumatic placement within the coronary artery,” and
`this feature allows removal of the tapered inner catheter after the coaxial
`guide catheter is in place. Id. at 3:23–28.
`Figures 1 and 2, reproduced below, show a coaxial guide catheter and
`a tapered inner catheter in accordance with the invention described in
`the ’116 patent:
`
`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`inner catheter separately, and Figure 2 depicts those two elements assembled
`together. Id. at 5:51–56; Figs. 1 and 2. As shown above, “coaxial guide
`catheter assembly 10” includes coaxial guide catheter 12 and tapered inner
`catheter 14. Id. at 6:42–44. Coaxial guide catheter 12 includes tip
`
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`Patent RE46,116 E
`portion 16, reinforced portion 18, and rigid portion 20. Id. at 6:45–46.
`Tapered inner catheter 14 “includes tapered inner catheter tip 42.” Id.
`at 7:26–27. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 7:30–31. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50 (not labeled in
`figures above). Id. at 7:31–32. “Tapered inner catheter 14 may also include
`clip 54 at a proximal end thereof to releasably join tapered inner catheter 14
`to coaxial guide catheter 12.” Id. at 7:35–37. “The tapered inner catheter
`provides a gradual transition from the standard 0.014 inch diameter
`guidewire to the diameter of the coaxial guide catheter which is typically
`five to eight French.” Id. at 3:28–31. The coaxial guide catheter is made in
`at least three sizes corresponding to sizes commonly used in interventional
`cardiology procedures. Id. at 3:39–42.
`Figure 4, reproduced below, shows a coaxial guide catheter in
`accordance with the invention described in the ’116 patent:
`
`Figure 4 is a sectional view of the coaxial guide catheter with tip portion 16
`depicted on the left side of the figure (rather than on the right side as shown
`in Figures 1 and 2). Id. at 5:60; Fig. 4. As shown above, coaxial guide
`catheter 12 has rigid portion 20 that “includes first full circumference
`portion 34, hemicylindrical portion 36, arcuate portion 38, and second full
`
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`IPR2020-01343
`Patent RE46,116 E
`circumference portion 40” (second full circumference portion 40 is shown in
`Figure 3). Id. at 7:7–10.
`In operation, a guide catheter and a guidewire are used along with the
`coaxial guide catheter and the tapered inner catheter. Ex. 1001, 8:20–22.
`Figure 8, reproduced below, shows the operation of the coaxial guide
`catheter assembly in accordance with the invention described in the ’116
`patent:
`
`
`Figure 8 is a schematic view of a guide catheter and a guide wire in use with
`the coaxial guide catheter assembly within the aortic arch and coronary
`artery. Id. at 6:5–8; Fig. 8. First, guidewire 64 is inserted and passed
`through aortic arch 58 into ostium 60 of coronary artery 62. Id. at 7:65–66.
`Guide catheter 56 is then passed over guidewire 64 until the distal end of
`guide catheter 56 is seated in ostium 60. Id. at 8:4–6. Next, coaxial guide
`catheter 12 with tapered inner catheter 14 is passed through guide
`catheter 56 and over guidewire 64 into coronary artery 62. Id. at 8:22–24.
`The presence of coaxial guide catheter 12 within guide catheter 56 “provides
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`IPR2020-01343
`Patent RE46,116 E
`stiffer back up support than guide catheter 56 alone.” Id. at 8:38–40. “Once
`the coaxial guide catheter-tapered inner catheter combination has been
`inserted sufficiently into the ostium of the coronary artery to achieve deep
`seating the tapered inner catheter may be removed.” Id. at 4:58–62; see also
`id. at 8:30–32. Thereafter, coaxial guide catheter 12 can “accept a treatment
`catheter such as a stent or a balloon catheter.” Id. at 8:33–34. “[T]he
`presence of the coaxial guide catheter provides additional backup support to
`make it less likely that the coaxial guide catheter guide catheter combination
`will be dislodged from the ostium of the coronary artery while directing the
`coronary therapeutic device past a tough lesion.” Id. at 5:2–6. “[T]he
`invention is deliverable through an existing hemostatic valve arrangement on
`a guide catheter without preventing injections through existing Y adapters.”
`Id. at 5:42–44.
`
`D. Illustrative Claim of the ’116 Patent
`Petitioner challenges claims 25–40, 42, 44–48, 52, and 53 of
`the ’116 patent. Pet. 1. Claims 25 and 52 are independent method claims.
`Ex. 1001, 13:62–14:25, 17:10–18:10. Claims 26–40, 42, and 44–48 depend
`from claim 25 and claim 53 depends from claim 52. Id. at 14:26–15:41,
`15:47–50, 18:11–14. Claim 25 is illustrative of the claimed subject matter
`and is reproduced below.
`25. A method, comprising:
`advancing a distal end of a guide catheter having a lumen through
`a main blood vessel to an ostium of a coronary artery;
`advancing a distal end of a guide extension catheter through, and
`beyond the distal end of, the guide catheter, including
`advancing a distal end portion of a tubular structure of the
`guide extension catheter beyond the distal end of the guide
`catheter while a segment defining a side opening of the guide
`extension catheter remains within the guide catheter the side
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`opening extending for a distance along a longitudinal axis of
`the guide extension catheter and accessible from a longitudinal
`side defined transverse to the longitudinal axis, the tubular
`structure having a cross-sectional inner diameter that is not
`more than one French size smaller than a cross-sectional inner
`diameter of the lumen of the guide catheter;
`maintaining the distal end portion of the tubular structure of the
`guide extension catheter in position beyond the distal end of
`the guide catheter; and
`while maintaining the distal end of the guide extension catheter
`positioned beyond the distal end of the guide catheter
`advancing a balloon catheter or stent at least partially through
`the guide catheter and the guide extension catheter and into the
`coronary artery, including advancing the balloon catheter or
`stent through a hemostatic valve associated with a proximal
`end of the guide catheter, along a substantially rigid segment
`of the guide extension catheter, through the side opening, and
`through the tubular structure.
`Id. at 13:62–14:25.
`
`E. References and Testimony
`Petitioner’s contentions rely, in part, on testimony from Dr. Brecker,
`Dr. Hillstead, and Mr. Jones. Dr. Brecker states that he has been an
`interventional cardiologist for over twenty-four years, that he has been Chief
`of Cardiology at St. Georges University Hospitals London since 2015, and
`that he is a Professor of Cardiology and Chief of Cardiology Clinical
`Academic Group at St. George’s University. Ex. 1005 ¶¶ 4, 5, 7.
`Dr. Hillstead states that he is CEO of a medical device development and
`entrepreneurship consulting firm, the Chairman of a wound healing device
`company, a named inventor on numerous patents and pending applications
`related to catheter design, and that he has been involved in the design and
`development of medical devices for more than thirty years. Ex. 1042 ¶¶ 5,
`10, 12. Mr. Jones states that he has worked in contract mechanical
`
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`IPR2020-01343
`Patent RE46,116 E
`engineering since 1997 on projects including “prototype designs for
`minimally invasive, surgical, and implantable devices, development and
`fabrication for surgical devices, test fixture design and fabrication, and
`process validation,” that he previously worked as an engineer on medical
`device design, development and manufacturing, including on catheters, and
`that he is a named inventor on over 100 patents. Ex. 1807 ¶¶ 8–10.
`Patent Owner’s arguments rely, in part, on testimony from Mr. Keith
`and Dr. Graham. Mr. Keith states that his work between 1987 and 1996 as
`an engineer at a medical device company focused in the field of
`interventional cardiology and catheter design, that since 1997 he has served
`as an independent consultant for early stage medical device companies in
`product design and intellectual property development, that he co-founded a
`medical device company “focused on catheter-based treatments for chronic
`sinusitis,” and that he is a named inventor on over 140 patents. Ex. 2138
`¶¶ 3–6. Dr. Graham states that he is an interventional cardiologist at
`St. Michael’s Hospital, an Assistant Professor in the Division of Cardiology
`at the University of Toronto, and that he has over twenty years of experience
`in interventional cardiology. Ex. 2145 ¶ 1.
`Below we provide a table identifying the references asserted.
`
`References
`
`Date
`
`June 15, 2010
`U.S. Patent No. 7,736,355 B2 (“Itou”)
`U.S. Patent No. 7,604,612 B2 (“Ressemann”) October 20, 2009
`US 2005/0015073 A1 (“Kataishi”)
`January 20, 2005
`
`Ex.
`No.
`1007
`1008
`1025
`
`
`
`11
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`IPR2020-01343
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`
`F. Asserted Grounds of Unpatentability
`Petitioner alleges unpatentability of the Challenged Claims on the
`following grounds:
`Claim(s) Challenged
`52, 53
`25–40, 42, 44–48, 52, 53
`45
`Pet. 8–9.
`
`References/Basis
`Ressemann
`Itou, Ressemann
`Itou, Ressemann, Kataishi
`
`35 U.S.C. §
`102
`103
`103
`
`II. MOTION TO EXCLUDE
`The party moving to exclude evidence bears the burden of proving
`that it is entitled to the relief requested—namely, that the material sought to
`be excluded is inadmissible under the Federal Rules of Evidence (“FRE”).
`See 37 C.F.R. §§ 42.20(c), 42.62(a) (2019). In an inter partes review in
`which we both decide admissibility and serve as the fact-finder, we are well-
`positioned to determine and assign appropriate weight to evidence presented,
`and we recognize that a complete record of the evidence is preferable to
`facilitate public access as well as appellate review. See, e.g., Sony Computer
`Entm’t Am. LLC v. Game Controller Tech. LLC, IPR2013-00634,
`Paper 32 at 31 (PTAB Apr. 14, 2015); see also Gnosis S.p.A. v. S. Alabama
`Med. Sci. Found., IPR2013-00118, Paper 64 at 43 (PTAB June 20, 2014)
`(citing Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941)
`(“If the record on review contains not only all evidence which was clearly
`admissible, but also all evidence of doubtful admissibility, the court which is
`called upon to review the case can usually make an end of it, whereas if
`evidence was excluded which that court regards as having been admissible, a
`new trial or rehearing cannot be avoided.”)).
`
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`Petitioner moves to exclude Exhibit 2024, a document titled “Product
`Requirements: Guideliner Catheter System,” as well as certain portions of
`the deposition testimony of Steven Erb (specifically, Ex. 1799, 37:2–7,
`37:20–38:6, 39:17–40:20). Paper 65 (the “Motion” or “Mot.”); see also
`Paper 74 (Petitioner’s reply in support of its motion to exclude). Patent
`Owner opposes the Motion. Paper 69 (“Mot. Opp.”).
`Petitioner contends that Exhibit 2024 is unreliable on its face and that
`none of Patent Owner’s witnesses can authenticate the document. Mot. 2–9.
`Patent Owner responds that Exhibit 2024 is authenticated under FRE 901
`based on the declaration and/or deposition testimony of Mr. Peterson
`(Ex. 2252 ¶ 18), Ms. Schmalz (Ex. 2039 ¶¶ 6–7), Mr. Root (Ex. 2118 ¶ 57),
`and Mr. Sutton (Ex. 2119 ¶ 44). Mot. Opp. 3–8.
`Documents are authenticated by evidence “sufficient to support a
`finding that the item is what the proponent claims it is.” Fed. R.
`Evid. 901(a); see Fox Factory v. SRAM, LLC, IPR2016-01876, Paper 59
`at 63 (PTAB Apr. 2, 2018) (quoting same). “Authenticity is, therefore, not
`an especially high hurdle for a party to overcome.” Fox Factory, Paper 59
`at 63 (citing United States v. Patterson, 277 F.3d 709, 713 (4th Cir. 2002)).
`We determine that Exhibit 2024 has been authenticated under the low
`bar required under Federal Rule of Evidence 901 based on the evidence
`provided by Petitioner. See Mot. Opp. 2–11. In addition, Petitioner’s
`arguments go to the weight of the evidence and not its admissibility.
`Accordingly, we deny Petitioner’s Motion to Exclude. We note, however,
`that even if we were to exclude Exhibit 2024, it would not change the
`outcome or our general analysis of this case.
`
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`Petitioner also argues that the portions of the testimony of Mr. Erb it
`seeks to exclude are prejudicial, citing FRE 403. Mot. 10–15. We find
`Petitioner fails to show any prejudice. As Patent Owner explains, “[t]he
`testimony concerned subjects in Mr. Erb’s declaration and about which
`Petitioner had elicited testimony, Petitioner had the opportunity to (and did)
`re-cross Mr. Erb, and Petitioner had the opportunity to (and did) submit a
`sur-reply brief.” Mot. Opp. 11–14 (citing, e.g., Ex. 1799, 10:11–12:16,
`38:24–40:21; Ex. 2122 ¶¶ 17–20; IPR2020-01341, Paper 51, 14–15).
`Accordingly, we deny Petitioner’s motion to exclude testimony of Mr. Erb.
`We note, however, that even if we were to exclude the testimony at issue, it
`would not change the outcome or our general analysis of this case.
`III. ANALYSIS OF PATENTABILITY
`In our analysis of Petitioner’s unpatentability contentions with respect
`to the Challenged Claims, we next address the priority date of the ’116
`patent; applicable principles of law; the level of ordinary skill in the art; the
`proposed construction of claim terms; the scope and content of the asserted
`prior art; and then further analyze Petitioner’s contentions with respect to
`each alleged ground of unpatentability for purposes of determining whether
`Petitioner shows by a preponderance of the evidence the unpatentability of
`the Challenged Claims.
`A. Priority Date of the ’116 Patent
`Petitioner argues that “[t]he ’116 patent is subject to the AIA[5] first-
`to-file provisions because (1) it contains claims that lack written description,
`and therefore pre-AIA priority, and (2) it claims priority to RE 45,380
`
`
`5 Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125 Stat.
`284 (2011).
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`(“the ’380 patent”), which is subject to the AIA first-to-file provisions.”
`Pet. 12–13. Petitioner contends that because there is no written description
`support for the subject matter of at least claim 27 of the ’380 patent and
`claim 45 of the ’116 patent, the ’116 patent has an effective filing date after
`March 16, 2013. Id. at 12–13. Thus, according to Petitioner, the ’116 patent
`is subject to the AIA’s first-to-file provisions, which precludes Patent Owner
`from attempting to swear behind Itou’s filing date. Id. Patent Owner argues
`that the Board previously rejected Petitioner’s arguments concerning
`the ’380 patent, and that Petitioner’s arguments here likewise fail. PO
`Resp. 5–9; see also Medtronic Inc. and Medtronic Vascular, Inc., v. Teleflex
`Innovations S.À.R.L., IPR2020-00128, Paper 127 (PTAB June 7, 2021).
`The first-to-file provisions apply to patent applications “that contain[]
`or contained at any time a claim to a claimed invention that has an effective
`filing date” on or after March 16, 2013. AIA § 3(n)(1). The application for
`reissue for the ’116 patent was filed March 3, 2014, and sought reissue of
`U.S. Patent No. 8,292,850, which issued October 23, 2012, from an
`application filed January 26, 2012. Ex. 1001, codes (22), (64). “The
`effective filing date for a claimed invention in an application for reissue or
`reissued patent shall be determined by deeming the claim to the invention to
`have been contained in the patent for which reissue was sought.” 35 U.S.C.
`§ 100(i)(2) (2018). As the “patent for which reissue was sought” in this case
`was issued October 23, 2012, we are not persuaded that the AIA’s first-to-
`file provisions apply to the ’116 patent. Indeed, Petitioner provides no legal
`support for the proposition that claims in a reissue patent are not entitled to a
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`filing date as if they appeared in the original patent for which reissue was
`sought.6
`
`B. Principles of Law
`Under one ground, Petitioner contends that claims of the ’116 patent
`are unpatentable based on anticipation. Pet. 23–31. A claim is anticipated if
`a single prior art reference either expressly or inherently discloses every
`limitation of the claim. Orion IP, LLC v. Hyundai Motor Am., 605 F.3d 967,
`975 (Fed. Cir. 2010). “A single prior art reference may anticipate without
`disclosing a feature of the claimed invention if such feature is necessarily
`present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc.,
`754 F.3d 952, 958 (Fed. Cir. 2014) (citing Schering Corp. v. Geneva
`Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)).
`Petitioner contends under two grounds that claims of the ’116 patent
`are unpatentable based on obviousness. Pet. 32–80. As set forth in
`35 U.S.C. § 103(a),
`[a] patent may not be obtained . . . if the differences between the
`subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the
`time the invention was made to a person having ordinary skill in
`the art to which said subject matter pertains.
`The question of obviousness is resolved on the basis of underlying factual
`determinations including (1) the scope and content of the prior art; (2) any
`differences between the claimed subject matter and the prior art; (3) the level
`of ordinary skill in the art; and (4) when in evidence, objective evidence of
`
`
`6 To the extent the original patent for which reissue was sought does not
`contain written description support for a reissue claim, that claim may be
`invalid. But this is a question we may not address in an IPR. 35 U.S.C.
`§ 311(b).
`
`16
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`An obviousness analysis “need not seek out precise teachings directed to the
`specific subject matter of the challenged claim, for a court can take account
`of the inferences and creative steps that a person of ordinary skill in the art
`would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007);
`accord In re Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007).
`However, Petitioner cannot satisfy its burden of proving obviousness by
`employing “mere conclusory statements.” In re Magnum Oil Tools
`Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Instead, Petitioner must
`articulate a reason why a person of ordinary skill in the art would have
`combined the prior art references. In re NuVasive, 842 F.3d 1376, 1382
`(Fed. Cir. 2016).
`
`C. Level of Ordinary Skill in the Art
`In determining whether an invention would have been obvious at the
`time it was made, 35 U.S.C. § 103 requires us to resolve the level of
`ordinary skill in the pertinent art at the time of the invention. Graham,
`383 U.S. at 17. The person of ordinary skill in the art is a hypothetical
`person who is presumed to have known the relevant art at the time of the
`invention. In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In
`determining the level of ordinary skill in the art, various factors may be
`considered, including the “type of problems encountered in the art; prior art
`solutions to those problems; rapidity with which innovations are made;
`sophistication of the technology; and educational level of active workers in
`the field.” Id.
`Petitioner contends that a person of ordinary skill in the art at the time
`of the invention would have been either: (1) a medical doctor who would
`have had “(a) a medical degree; (b) completed a coronary intervention
`
`17
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`training program, and (c) experience working as an interventional
`cardiologist;” or (2) an engineer who would have had “(a) an undergraduate
`degree in engineering, such as mechanical or biomedical engineering;
`and (b) at least three years of experience designing medical devices,
`including catheters or catheter-deployable devices.” Pet. 13–14.
`Additionally, Petitioner contends “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id. at 14. Further, according to Petitioner,
`a person of ordinary skill in the art “with a medical degree” and a person of
`ordinary skill in the art “with an engineering degree” may have had access to
`each other. Id. (citing Ex. 1005 ¶ 31; Ex. 1042 ¶¶ 18–19).
`Patent Owner does not dispute Petitioner’s proposed level of ordinary
`skill. PO Resp. 5. We adopt Petitioner’s proposed level of ordinary skill in
`the art as it is undisputed and consistent with the level of skill reflected in
`the prior art and the specification of the ’116 patent. See Okajima v.
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific
`findings regarding ordinary skill level are not required “where the prior art
`itself reflects an appropriate level and a need for testimony is not shown”)
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`163 (Fed. Cir. 1985)).
`As their qualifications are undisputed, we also determine that the
`parties’ experts are qualified to opine on the issues in this proceeding from
`the perspective of a person of ordinary skill in the art. Ex. 1042 ¶¶ 5, 10, 12
`
`18
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`(Dr. Hillstead’s qualifications);7 Ex. 1807 ¶¶ 8–10 (Mr. Jones’s
`qualifications); Ex. 2138 ¶¶ 3–6 (Mr. Keith’s qualifications); Ex. 2145 ¶ 1
`(Dr. Graham’s qualifications); see Kyocera Senco Indus. Tools Inc. v. Int'l
`Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert
`testimony from the perspective of a skilled artisan in a patent case . . . a
`witness must at least have ordinary skill in the art.”).
`D. Claim Construction
`“In an inter partes review proceeding, a claim of a patent . . . shall be
`construed using the same claim construction standard that would be used
`to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R.
`§ 42.100(b). That standard “includ[es] construing the claim in accordance
`with the ordinary and customary meaning of such claim as understood by
`one of ordinary skill in the art and the prosecution history pertaining to
`the patent.” Id.; see also Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.
`2005) (en banc).
`Petitioner proposes the following constructions: (1) “substantially
`rigid” as “rigid enough to allow the device to be advanced within the guide
`catheter,” (2) “side opening” needs no construction and should be given
`its plain and ordinary meaning, (3) “lumen” as “the cavity of a tube,”
`and (4) “flexural modulus” as “[a] measure of resistance . . . to bending.”
`
`7 Patent Owner argues that Dr. Hillstead does not meet the definition of a
`person of ordinary skill in the art because he lacks a four-year undergraduate
`degree in engineering. PO Resp. 5 n.1 (citing, e.g., Ex. 2137, 462:8–13). As
`noted above, however, it is undisputed that “[e]xtensive experience and
`technical training might substitute for education.” Pet. 14. Patent Owner
`does not address Dr. Hillstead’s significant professional experience, which
`we find sufficient to show he is qualified to opine on the issues in this
`proceeding from the perspective of a
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